Exelixis, Inc. (NASDAQ:EXEL) Q2 2023 Earnings Call Transcript

Michael Morrissey: And then on the question regarding Teva, as probably won’t be a surprise to you, I’m somewhat low to comment on — in much detail on that settlement. So I would say into relatability to other settlements or other things we might do in the future, we’re certainly very pleased to have the action date that we got in the Teva settlement of January 1st. 2031. And I think that’s consistent with some of the messaging we’ve been sending over time. And obviously, we’re going to continue to be very aggressive about protecting our IP going forward. So but as you would imagine, can’t really say much about how the two would interact.

Jason Gerberry: Had to try.

Vicki Goodman: Thanks, Jason.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Michael Schmidt: Hey, guys, thanks for taking my questions. I had one on the upcoming CONTACT-02 study data. Could you remind us what the bar is for second — for PFS for a second hormone therapy in this population? And you obviously have dual endpoints PFS and OS, is there potential opportunity to file just based on PFS or would you need both endpoints in order to file for this indication? And then I had a bigger picture follow-up.

Vicki Goodman: Yes, thanks for the question, Michael. So in terms of the bar, again these are patients with metastatic castration-resistant prostate cancer who have already received first non-hormonal therapy. So they tend not to have actually quite short PFS on their second line NHC which has given in advance of chemotherapy, so somewhere on the order of about 2.5 to 4 months PFS. In terms of would we file on PFS alone or OS? What I would say is, we’re going to evaluate the totality of the data, as they come in, in terms of the overall benefit risk profile that we see and if appropriate, we’ll have those conversations with the regulatory authorities.

Michael Schmidt: Great, thanks. And then thanks for the additional detail on your R&D efforts and pipeline activities. So obviously you’re focusing more now on advancing internal programs into clinical development. To what degree does that affect your business development strategy? Is that still a priority at this point given your strong balance sheet? Or are you shifting more towards investing into the internal pipeline capabilities? Thanks so much.

Michael Morrissey: Yeah, Michael, it’s Mike. Yeah, no, that’s a great question and thanks for that. We specifically added a bullet in my intro around BD and our interest and the priority we have in continuing our business development activities to access new clinical assets. So that’s a priority for us. Again, we’re agnostic to where high conviction assets come from. I wish to make a lot of progress on our internal R&D efforts, but there’s still some molecules out there that we like a lot, that we’re pursuing. So that’s still an important part of our process. And again, no guarantee will be able to complete those transactions, but it’s certainly a main focus for us right now.

Michael Schmidt: Great. Thanks so much.

Vicki Goodman: Thanks, Michael.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Andy Hsieh with William Blair. Your line is open.

Andy Hsieh: Thanks for taking our questions. I got a couple here. So, Vicki, thanks for the update regarding the STELLAR-303 study. I’m just curious about this emerging observation about liver mets. Is that dependent on the RAS status, whether it’s mutated or wild type? Just kind of curious about that two variable at a two-by-two metrics.